BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 12436036 · Received September 7, 2021

    Report

    Report Number
    2029214-2021-01118
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    September 1, 2017
    Report Date
    September 7, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BILGIN, C., DURMUS, Y., HAKI, C. ET AL. DIRECT ASPIRATION THROMBECTOMY EXPERIENCE WITH THE SOFIA 6F CATHETER IN ACUTE ISCHEMIC STROKE. JPN J RADIOL 39, 605¿610 (2021). DOI.ORG/10.1007/S11604-021-01090-Z A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BILGIN, C., DURMUS, Y., HAKI, C. ET AL. DIRECT ASPIRATION THROMBECTOMY EXPERIENCE WITH THE SOFIA 6F CATHETER IN ACUTE ISCHEMIC STROKE. JPN J RADIOL 39, 605¿610 (2021). DOI.ORG/10.1007/S11604-021-01090-Z MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE USEFULNESS OF THE SOFIA 6F CATHETER IN MECHANICAL THROMBECTOMY WITH THE DIRECT ASPIRATION FIRST PASS TECHNIQUE. THE AUTHORS REVIEWED 148 CASES OF PATIENTS TREATED FOR ACUTE ISCHEMIC STROKE BETWEEN SEPTEMBER 2017 TO JANUARY 2019 USING DIRECT ASPIRATION THROMBECTOMY. OF THE 148 PATIENTS, THE AVERAGE AGE WAS 64 YEARS, 67 WERE FEMALE AND 81 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE REBAR MICROCATHETER OR SOLITAIRE STENT RETRIEVER. THERE WAS NO COMPLICATION DIRECTLY RELATED TO THE SOFIA CATHETER. IT WAS NOTED INITIAL ASPIRATION THROMBECTOMY COULD NOT BE PERFORMED IN 18 PATIENTS DUE TO EXTREME TORTUOSITY, INSUFFICIENT CATHETER LENGTH, OR SEVERE STENOSIS. SUCCESSFUL RECANALIZATION WAS ACHIEVED IN 90 PATIENTS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 1. 8 PATIENTS EXPERIENCED SYMPTOMATIC INTRACRANIAL HEMORRHAGE WHICH INCREASED THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE BY 4 POINTS OR MORE WITHIN 24 HOURS. 8 PATIENTS EXPERIENCED EMBOLIZATION TO NEW TERRITORIES. REFER TO MANUFACTURER REPORT 2029214-2021-01116 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329477 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention